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Effects of Type II Collagen Association on Muscle Strength in Pain and Function of Patients with Knee Arthrosis

Effects of the combination of the non-denatured collagen type II (UC-II®) and the Russian current muscle reinforcement on the pain and function of patients with osteoarthritis of the knee: a randomized double-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8ghcx3
Enrollment
Unknown
Registered
2019-07-08
Start date
2016-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Interventions

Collagen group, with 20 subjects, receiving 40 mg of oral collagen without interruption once a day for 90 days. Collagen placebo group, with 20 subjects, receiving collagen placebo 40 mg uninterrupted
Procedure/surgery
Dietary supplement
G07.203.300.456
E02.331.800

Sponsors

Universidade Luterana do Brasil
Lead Sponsor
Universidade Luterana do Brasil
Collaborator

Eligibility

Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: Men and women 40 to 75 years of age (this age group is justified because it covers the subjects with the stage of evolution of osteoarthritis of degree I to III); Unilateral and bilateral knee osteoarthritisfor more than three months with classification I to III in the radiological classification of Kelgren Lawrence confirmed by orthopedic doctor; Functional score of Lequesne higher than 4.5; Availability of dedication to treatment during the study period (six months); Patient agrees not to initiate any new physical or drug therapy for knee OA during the study period; Have signed the Term of Free and Informed Consent.

Exclusion criteria

Exclusion criteria: Grade IV knee osteoarthritis in the Kellgren-Lawrence radiological classification confirmed by orthopedist; Non-ambulatory; History of inflammatory arthropathy, septic arthritis, rheumatoid arthritis, inflammatory joint disease, uric acid gout, joint fracture, fibromyalgia, collagen genetic disease; Neurological diseases leading to cognitive deficits; History of asthma or type I or II diabetes; Psychiatric disorders; Symptomatic heart disease; Patients with clinical manifestations that do not allow the accomplishment of exercises; Presence of a skin or other type of skin disease at the level of the thigh; Urinary incontinence; Pregnancy; Alcoholism; Cancer; Patients with previous history of joint infiltration of corticoid or viscossuplementation in the knee in the last three months; History of trauma or knee surgery in the last six months; Three consecutive absences not justified physical rehabilitation.

Design outcomes

Primary

MeasureTime frame
Mean difference in pain level in the knee evaluated through the Visual Analog Pain Scale (VAS) from pre to post intervention, 90 days and 6 months after the intervention after the intervention, based on the observation of a variation of at least 5% in pre and post-intervention..

Secondary

MeasureTime frame
Mean difference at the level of muscular strength in the knee evaluated by manual dynamometry from pre to post intervention, 90 days and six months after intervention, based on the observation of a variation of at least 5% in pre and post intervention measurements.

Countries

Brazil

Contacts

Public ContactMarcelo Dohnerrt

Universidade Luterana do Brasil

mdohnert@hotmail.com+55 053 984632952

Outcome results

None listed

Source: REBEC (via WHO ICTRP)